Manufacturing Technician IV, Lead - Inspection

Resilience•Blue Ash, OH

1d•$26 - $41

About The Position

The Manufacturing Technician IV, Lead reports to a Supervisor/Manager on the Manufacturing floor and leads complex Inspection floor activities. The Technician serves as a technical resource for the team, performs advanced-level documentation review, maintains qualification standards, and drives continuous improvement in partnership with Process Facilitators and Engineers. This role begins on a Monday–Friday, 8-hour project schedule and then transitions to a rotating 2-2-3 schedule of 12-hour day shifts. The company may modify schedules, including requesting overtime, based on business and operational needs. The role is primarily non-sedentary and may involve climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects. It involves visual tasks such as reviewing data and figures, viewing computer terminals, extensive reading, and operating machinery. Employees participate in an occupational health program, which may include medical assessments, surveillance, vaccination, and testing, and use personal protective equipment such as respirators, PAPRs, gowns, gloves, face protection, and other barrier equipment. The candidate must pass an eye exam during onboarding. Employees must follow the company’s Quality Management System, Quality Manual, Quality Policy, SOPs, cGMPs, and other applicable regulations and standards. Sponsorship or support for work authorization, including visas, is not available.

Requirements

Significant experience in pharmaceutical, biotechnology, or cGMP-regulated manufacturing, including expertise across inspection types and equipment and prior experience leading floor execution.
Knowledge of cGMP requirements, inspection processes, documentation practices, and investigation support.
Mastery of visual defect detection and inspection accuracy across all material types handled on the floor.
Strong organizational, analytical, and problem-solving skills, including the ability to independently prioritize operations.
Ability to read, write, speak, and understand English to communicate technical information cross-functionally.
Experience providing on-the-job training or technical guidance to peers while fostering compliance and continuous improvement.
Ability to work effectively as part of a team in a fast-paced production environment.
Ability to perform the physical and visual tasks described for the role and pass an eye exam during onboarding.

Nice To Haves

High school, vocational school, or equivalent education.
Four or more years of experience in pharmaceutical, biotechnology, or cGMP-regulated manufacturing.
Prior inspection experience.
Experience tracking and reporting metrics.
Experience contributing to inspection-process improvements, deviation investigations, and qualification programs.
Experience in a lean manufacturing environment.
Working knowledge of Microsoft applications, SAP, and/or Veeva Vault.

Responsibilities

Lead and monitor inspection process activities to ensure successful production-floor operations.
Perform inspection activities as needed to support floor coverage and maintain qualifications.
Perform inventory control and reconciliation using SAP and WES.
Execute protocols for equipment qualification and process validation as required.
Ensure production-floor work follows SOPs and cGMPs.
Support lean activities, including 5S, problem-solving, and serving as a continuous-improvement project resource for the Process Execution Team.
Complete advanced-level batch record and GMP documentation entries, including complex or non-routine documentation, and guide team members on documentation accuracy.
Access and print current-revision SOPs and forms through ECMS.
Follow job-related safety procedures, including PPE use, LOTO, ergonomics, and chemical handling.
Use SOPs, forms, and batch records to guide work in accordance with SOPs and cGMPs.
Maintain required certifications and qualifications for the assigned work area.
Provide technical and subject-matter guidance to production and mechanical technicians.
Serve as a certified on-the-job trainer for assigned equipment and process tasks, training and supporting team members.
Support team members in maintaining required qualifications and certifications.
Collaborate with Process Facilitators and Engineers on inspection-floor initiatives.
Make independent decisions, prioritize work, and guide team members on daily production activities.
Support deviation investigations, CAPA execution, and SOP revisions as the inspection-floor subject-matter expert.
Attend and actively participate in daily Tier 1 meetings.